- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01244542
Pain and Schizophrenia
October 4, 2017 updated by: University Hospital, Strasbourg, France
The aim of the investigators project is to explore the mechanisms of pain insensitivity in patients with schizophrenia, in order to prevent its invalidating consequences.
The investigators will couple methods of experimental psychology with EEG and blood samplings, in order to distinguish the role of non-painful perception, attention, aversive effects, and pain expression, and the investigators will explore an original neurobiological hypothesis regarding the activation of opioid receptors.
Study Overview
Study Type
Interventional
Enrollment (Actual)
83
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Besançon Cedex, France, 25030
- Service de Psychiatrie Adulte2, Place Saint-Jacques - ZA 481, Centre Hospitalier Saint-Jacques
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Erstein Cedex, France, 67152
- Service de Psychiatrie Adulte, Secteur G11, Centre Hospitalier de Erstein, 13 route de Krafft
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Strasbourg Cedex, France, 67 091
- Centre d'évaluation et de traitement de la douleur, Hôpitaux Universitaires de Strasbourg
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Strasbourg Cedex, France, 67091
- Centre d'Investigation Clinique - Hôpitaux Universitares de Strasbourg
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Strasbourg cedex, France, 67091
- Service de Psychiatrie - Hôpitaux Universitaires de Strasbourg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with schizophrenia (criteria DSM IV) or healthy controls matched with patients on age, sex and education level
- 18-55 years old
Exclusion Criteria:
- Past history affecting CNS
- Intake of psychotropic drugs, except for patients
- Metabolic disorder affecting sensory processing (diabetes)
- Intake of benzodiazepines
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with schizophrenia
|
|
Active Comparator: Healthy controls
controls matched with patients on age, sex and education level
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Unpleasant stimuli
Time Frame: during experimental session
|
acute electrical stimulation
|
during experimental session
|
Unpleasant stimuli
Time Frame: during experimental session
|
emotional pictures
|
during experimental session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Anne Giersch, MD, University Hospital, Strasbourg, France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2011
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
November 17, 2010
First Submitted That Met QC Criteria
November 18, 2010
First Posted (Estimate)
November 19, 2010
Study Record Updates
Last Update Posted (Actual)
October 5, 2017
Last Update Submitted That Met QC Criteria
October 4, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4706
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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